(NASDAQ: ZLCS), a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases, today announced that it is has successfully completed a Phase 1 single ascending dose (SAD) clinical study with Z944, its novel, oral, T-type calcium channel blocker. The study results indicate that Z944 was generally well-tolerated and a maximum tolerated dose was achieved. Z944 will advance into a Phase 1 multiple ascending dose (MAD) study in the third quarter of 2012. Assuming Z944 successfully completes the MAD study, Z944 could enter Phase 2 clinical development in the first quarter of 2013.
“Based on their unique mechanism of action, T-type calcium channel blockers such as Z944 have the potential to provide relief of pain and other symptoms in patients suffering from acute and chronic inflammatory pain, such as post-operative pain, fibromyalgia and inflammatory bowel syndrome, which are significant disease areas in which novel agents with improved tolerability, efficacy, and long-term safety profiles are needed," commented Mark H.N. Corrigan, MD, President and CEO of Zalicus. “Zalicus is a leader in the discovery and development of Ion channel blockers, with unique expertise in N and T-type calcium channel and sodium channel blockers, and an emerging pipeline of Ion channel blocker drug candidates, including Z160 our oral, N-type calcium channel blocker which is poised to enter Phase 2a clinical trials in neuropathic pain indications in the third quarter of 2012.”
About Z944 and T-type Calcium Channel Blockers
Z944, is a novel, oral, T-type calcium channel blocker that has demonstrated preclinical efficacy in multiple inflammatory pain models. A Phase 1 clinical trial evaluating the safety and tolerability of Z944 is ongoing. If Z944 successfully completes this Phase 1 clinical trial, Zalicus is planning to advance Z944 into Phase 2 clinical development.
The wide distribution of T-type calcium channels found in brain, heart, endocrine cells and other tissues provides the possibility of developing therapeutics for multiple indications, including treatment of pain.